NCT02452112已完成2 期
An Open-Label, Single and Multiple-Dose, Two-Period, Consecutive Study in Healthy Chinese Subjects to Assess the Pharmacokinetic Profiles, Safety and Tolerability of Lidocaine Patch 5%.LIG13-CN-101 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 21
- 主要终点
- Change of VAS score
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of 5% lidocaine patch, following placebo or active patch applications in placebo insensitive subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 18 to 85 years of age.
- •Subjects must have herpes zoster associated pain present for ≥1 months after healing of the acute herpes zoster skin rash and not located on the face, scalp; the diagnosis will be based on physical examination and review of available medical records confirming an episode of herpes zoster.
- •Herpes zoster associated pain must be of at least moderate severity, defined as the average pain level ≥40 mm on a 100 mm visual analog scale (VAS slide ruler)
排除标准
- •Subjects with signs of cord or brainstem injury from herpes zoster.
- •Presence of another pain problem of greater severity than their herpes zoster associated pain.
- •Subjects who have undergone neurolytic nerve blocks or ablative neurosurgical procedures for control of herpes zoster associated pain
研究组 & 干预措施
Lidocaine
Active Comparator
Active arm with administration of active 5% Lidocaine patch
干预措施: 5% Lidocaine patch (Drug)
Placebo
Placebo Comparator
Placebo arm with administration of placebo patch
干预措施: Placebo (Drug)
结局指标
主要结局
Change of VAS score
时间窗: over 24 hour from baseline to the post-treatment over time during double-blind period
Mean change in the mean pain VAS score
次要结局
未报告次要终点
研究者
研究点 (21)
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